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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P170038 / PAS001 |
| Date Original Protocol Accepted |
05/22/2020
|
| Date Current Protocol Accepted |
08/19/2021
|
| Study Name |
CentriMag FTW PAS
|
| Device Name |
CentriMag Circulatory Support System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The PAS is a prospective, single-arm clinical investigation designed to evaluate the continued safety and effectiveness of the CentriMag Circulatory Support System for patients who fail-to-wean from CPB. The study is intended to assess whether post-approval use of the CentriMag PAS enrolling real-world subjects produces results that are comparable to those reported in the CentriMag Pivotal Clinical Study. The study will only involve new enrollees with new data collection.
|
| Study Population |
Subjects greater than 18 years of age who have been implanted with a CentriMag Circulatory Support System due to failure-to-wean from cardiopulmonary bypass. Subjects or their legal representative must also have signed the Informed Consent Form.
|
| Sample Size |
The PAS will enroll up to thirty-two (32) subjects. This is equal to the number of subjects enrolled in the CentriMag pivotal trial. Assuming a primary endpoint success rate of 67%, enrolling 32 subjects will give a power of 0.994 to reject the null hypothesis at an alpha of 0.025.
|
| Key Study Endpoints |
The primary endpoint includes:
a) In patients who recover and do not go onto transplantation or a long-term device:
The proportion of subjects surviving to 30 days post CentriMag support or to hospital discharge (whichever is longer).
b) In patients who do not recover and are bridged to a transplant or a long-term system:
The proportion of subjects surviving to induction of anesthesia for surgery for transplant or a long-term device.
Secondary Endpoints:
Frequency and incidence of adverse events will be collected through 30 days post CentriMag support or hospital discharge (whichever is longer).
Frequency and incidence of adverse events will be collected through induction of anesthesia for surgery for subjects who are bridged to therapy requiring another surgical procedure.
Hemodynamic parameters will be collected at:
Baseline,
4 hours post CentriMag implant,
Daily during CentriMag support,
Prior to explant, induction of anesthesia for heart transplant, or long-term VAD
|
| Follow-up Visits and Length of Follow-up |
Hospital discharge or 30 days post CentriMag support (whichever is longer)
|
